PTS PANELS MULTI-CHEMISTRY CONTROLS

K022401 · Polymer Technology Systems, Inc. · JJY · Aug 21, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022401
• Device Name: PTS PANELS MULTI-CHEMISTRY CONTROLS
• Applicant: Polymer Technology Systems, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 21, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The PTS PANELS Multi-Chemistry Controls are intended for use to estimate precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation and are intended for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing as well as consumers at home.

Device Story

PTS PANELS Multi-Chemistry Controls are aqueous quality control materials containing cholesterol, triglycerides, ketone (B-hydroxybutyrate), and glucose. Used with BioScanner 2000 and CardioChek instruments; operated by healthcare professionals in physician offices, acute/convalescent care facilities, or by consumers at home. Controls serve to estimate precision and detect systematic analytical deviations arising from reagent or instrument variation. Users compare instrument results against established control ranges to verify system performance and ensure accuracy of patient testing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Aqueous-based quality control material. Contains cholesterol, triglycerides, ketone (B-hydroxybutyrate), and glucose. Designed for use with BioScanner 2000 and CardioChek instruments. Class I device (21 CFR 862.1660).

Indications for Use

Indicated for use as an assayed quality control material to estimate precision and detect systematic analytical deviations in reagent or instrument performance for healthcare professionals and home consumers.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Maine Standards Validate Chem 1 (K012117)
• Maine Standards Validate Chem 3 (K012119)

Submission Summary (Full Text)

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# AUG 2 1 2002

### SECTION E: 510(k) Summary

- 1. Application Date: July 19, 2002
Summary

K022401

## 2. Applicant Information: Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268

Contact Person: Margo Enright 317-870-5610 Phone Number: FAX Number: 317-870-5608 e-mail: [e-mail]

- 3. Trade Names: PTS PANELS Multi-Chemistry Controls
- 4. Classification Names: Assayed Quality Control Material

Panel: Clinical Chemistry 75 . Product Code: JJY

- 5. Facility Address: 7736 Zionsville Road Indianapolis, IN 46268
- 6. Device Classification: Class I (Regulation: 21 CFR 862.1660)

## 7. Device Description:

The PTS PANELS Multi-Chemistry Controls consist of multiple levels of aqueous controls containing cholesterol, triglycerides, ketone (Bhydroxybutyrate) and glucose.

#### 8. Intended Use:

The PTS PANELS Multi-Chemistry Controls are intended for use to estimate precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation and are intended for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing as well as consumers at home.

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- 9. Reason for 510(k): New Device

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#### 10. Predicate Device Information

The predicate devices for this submission for determination of substantial equivalence are the Maine Standards Validate Chem 1 and Chem 3.

# Information on Predicate Devices

| New Device | Predicate Device | K Number |
|-------------------------------------|------------------------------------|----------|
| PTS PANELS Multi-Chemistry Controls | Maine Standards<br>Validate Chem 1 | K012117 |
| PTS PANELS Multi-Chemistry Controls | Maine Standards<br>Validate Chem 3 | K012119 |

# Similarities and Differences Between Predicates and New Device

| Items Compared | Similarities | Differences |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PTS PANELS Multi-<br>Chemistry Controls and<br>Maine Standards Validate<br>Chem 1. | Both are aqueous.<br>Both contain glucose and<br>triglycerides. | The Maine Standards<br>Validate Chem 1 also<br>contains Na, K, Cl, Ca,<br>PO4, BUN, Cre, Mg, Lac,<br>NH3, ETOH and Li.<br><br>The PTS PANELS Multi-<br>Chemistry Controls also<br>contain cholesterol and<br>ketone ( <i>B</i> -<br>hydroxybutyrate) |
| PTS PANELS Multi-<br>Chemistry Controls and<br>Maine Standards Validate<br>Chem 3. | Both contain cholesterol. | The Maine Standards<br>Validate Chem 3 also<br>contains total protein,<br>albumin and Fe.<br><br>The PTS PANELS Multi-<br>Chemistry Controls also<br>contains glucose,<br>triglycerides and ketone<br>( <i>B</i> -hydroxybutyrate).<br><br>The Maine Standards<br>Validate Chem 3 is<br>protein based and the<br>PTS PANELS Multi-<br>Chemistry Controls are<br>aqueous. |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# AUG 2 1 2002

Ms. Margo Enright Manager of Clinical Affairs Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268

Re: k022401

> Trade/Device Name: PTS Panels Multi-Chemistry Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: July 19, 2002 Received: July 23, 2002

Dear Ms. Enright:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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# Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 10:5 Food al | Dorg Administration > Center for Devices and Radiological Health

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510(k) Number (if known : K022401

Device Name:

Indications for Use:

The PTS PANELS Multi-Chemistry Controls are intended for use on the BioScanner 2000 and CardioChek brand instruments to estimate precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation and are intended for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing as well as consumers at home.

Jan Cooper

(Division Sign-Off)
Ethical Laboratory Devices

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022401

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)